title: Importance of achieving the composite endpoints in diabetes.
abstract: Well-conducted randomized controlled trials are instrumental in providing vital data on safety and efficacy of new molecules under consideration for approval. However acquiring such data involves huge cost and focused scientific endeavor. Selection and reporting of endpoints of a therapy is essential to assess the effect(s) of an intervention on overall disease control and guidelines have suggested the use of composite endpoint (CEP) in clinical trial design over individual endpoints to demonstrate the compound effect. Composite endpoints have been preferred for their ability to assess the net clinical benefit of an intervention, avoid misinterpretation associated with competing risks, avoid the challenge of using a single outcome to validate the study objectives and reduce the sample size requirements in trials on patients treated for diabetes. Concerns for misinterpretation or difficulty in interpretation of trial results involving CEPs arise when differences in the components with respect to either clinical importance or event rates, or magnitude of treatment effect exist and when there's a possibility of biases due to competing risk. Suggestions for construction of composite endpoints and reporting the results of trials involving CEPs have been presented to improve the interpretations of overall effect of new interventions.
authors.affiliation: Department of Clinical Endocrinology, Chellaram Diabetes Institute, Budruk, Pune, Maharashtra, India.
authors.forename: Ambika Gopalakrishnan
authors.initials: AG
authors.lastname: Unnikrishnan
authors.forename: Arpandev
authors.initials: A
authors.lastname: Bhattacharyya
authors.forename: Manash Pratim
authors.initials: MP
authors.lastname: Baruah
authors.forename: Binayak
authors.initials: B
authors.lastname: Sinha
authors.forename: Mala
authors.initials: M
authors.lastname: Dharmalingam
authors.forename: Paturi V
authors.initials: PV
authors.lastname: Rao
keywords: Diabetes mellitus type 2; randomized controlled trials as topic; research design; treatment outcome